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In October 2017, Sanofi launched patent infringement litigation against Mylan’s NDA for generic versions of its Lantus vials and disposable injection pens. That litigation is still pending, with no trial date assigned. Read More
Stakeholders also argued that the new rule would have led to labels for the same drug temporarily bearing different labeling information between different generics… Read More
Sen. Cory Booker (D-N.J.) introduced legislation Tuesday designed to increase the transparency of drug coverage decisions made by state Medicaid programs, after an investigation gave rise to concerns of dishonest industry influence. Read More
Sen. Ron Wyden (D-Ore.) on Tuesday called on HHS Secretary Alex Azar to review the members of the department’s pain management task force for financial relationships with drug companies. Read More
Big name drug distributors and the DEA failed to stem the tide of millions of opioid doses into West Virginia despite plenty of warning signs, a House and Energy Commerce Committee report has found. Read More
Cancer trials that rely on event-free survival and complete response to treatment as surrogate endpoints will be acceptable to FDA reviewers, the agency says in a new final guidance issued Wednesday. Read More
Gottlieb said the agency is “going to be putting many more firms on notice that we’re aware that they’re manufacturing cell and tissue products that are subject to our oversight.” Read More
The PBMs, he said, have acquired new responsibilities and duties such as determining which medications are covered and how much money pharmacies are reimbursed for them. Read More
Baldwin called for detailed data on the price hikes, noting that in the wake of the 2017 tax reform bill, Pfizer received nearly $11 billion in tax benefits, almost all of which went to stock buybacks. Read More
Public Citizen questioned Gottlieb’s claim that the drug could help treat soldiers in battlefield settings, noting that the clinical trials only involved patients who underwent minor surgical procedures. Read More